MedPath

Desvenlafaxine

Generic Name
Desvenlafaxine
Brand Names
Pristiq
Drug Type
Small Molecule
Chemical Formula
C16H25NO2
CAS Number
93413-62-8
Unique Ingredient Identifier
NG99554ANW
Background

Desvenlafaxine (O-desmethylvenlafaxine) is the 0-demetyhlated active metabolite of venlafaxine. Like its parent drug, desvenlafaxine is also an antidepressant belonging to the class of serotonin-norepinephrine reuptake inhibitor (SNRI) class. It was approved by the FDA in 2008 for the treatment of adults with major depressive disorder (MDD).

MDD is a highly prevalent psychiatric disorder, with a lifetime prevalence estimate of 16% in the US alone and 12.8% in Europe. Although the exact mechanism of pathophysiology is still unknown, imbalances or deficiencies of monoamines have been heavily implicated, thus the rationale behind the use of SNRI to treat MDD. Desvenlafaxine has a very similar pharmacological, efficacy, and safety profile as venlafaxine. The major difference is the potential for drug interaction since venlafaxine is mainly metabolized by CYP2D6 while desvenlafaxine is conjugated by UGT; therefore, desvenlafaxine is less likely to cause drug-drug interaction when taken with medications affecting the CYP2D6 pathway.

Indication

Desvenlafaxine is indicated for the treatment of major depressive disorder in adults. It has also been used off-label to treat hot flashes in menopausal women.

Associated Conditions
Hot Flashes, Major Depressive Disorder (MDD)

The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

Phase 3
Completed
Conditions
Vasomotor Symptoms
Interventions
First Posted Date
2006-11-20
Last Posted Date
2011-10-26
Lead Sponsor
Pfizer
Target Recruit Count
500
Registration Number
NCT00401245
Locations

Pfizer Investigational Site

Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

Phase 1
Completed
Conditions
Vasomotor Symptoms
First Posted Date
2006-11-08
Last Posted Date
2007-12-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
32
Registration Number
NCT00397176

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2006-10-04
Last Posted Date
2012-03-15
Lead Sponsor
Pfizer
Target Recruit Count
638
Registration Number
NCT00384033
Locations
🇺🇸

Pfizer Investigational Site, Brown Deer, Wisconsin, United States

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

Phase 3
Completed
Conditions
Depression
Depressive Disorder
Depressive Disorder, Major
Interventions
First Posted Date
2006-08-29
Last Posted Date
2012-05-07
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
381
Registration Number
NCT00369343

Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women

Phase 3
Completed
Conditions
Menopause
Vasomotor System
First Posted Date
2006-08-29
Last Posted Date
2007-06-01
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
450
Registration Number
NCT00369434

Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Phase 3
Completed
Conditions
Depression
Depressive Disorder
Depressive Disorder, Major
First Posted Date
2006-08-21
Last Posted Date
2007-05-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
20
Registration Number
NCT00366652

Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects

Phase 3
Completed
Conditions
Healthy
First Posted Date
2006-05-24
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
14
Registration Number
NCT00329186

Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Phase 3
Completed
Conditions
Depression
First Posted Date
2006-05-24
Last Posted Date
2007-12-07
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
20
Registration Number
NCT00329147

Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

Phase 2
Terminated
Conditions
Fibromyalgia
First Posted Date
2006-03-10
Last Posted Date
2007-12-05
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
1050
Registration Number
NCT00301431

Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Phase 3
Completed
Conditions
Depressive Disorder, Major
First Posted Date
2006-03-08
Last Posted Date
2007-12-05
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
480
Registration Number
NCT00300378
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